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FDA actions in brief

FDA approved the etonogestrel 68-mg implant (Implanon, Organon), a single-rod implantable device that prevents pregnancy for up to 3 years.

Atripla

This fixed-dose combination tablet contains: efavirenz, a non-nucleoside reverse transcriptase inhibitor (NNRTI); emtricitabine, a synthetic nucleoside analog of cytidine; and tenofovir disoproxil, which is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate.

Sprycel

Dasatinib is an inhibitor of multiple tyrosine kinases and is active in vitro against leukemic cell lines representing variants of imatinib-sensitive and -resistant disease.

Prezista

This inhibitor of human immunodeficiency virus type 1 (HIV-1) protease selectively inhibits the cleavage of HIV-encoded Gag-Pol polyproteins in infected cells, thereby preventing the formation of mature virus particles.

Lucentis

This recombinant humanized IgG1 monoclonal antibody fragment binds to the receptor-binding site of active forms of human vascular endothelial growth factor A (VEGF-A).

A salmeterol/fluticasone combination (SFC) surpassed a formoterol/budesonide combination (FBC) in reducing the rate of moderate-to-severe exacerbations in patients with persistent asthma, according to a study published by the journal Respiratory Medicine.

Potassium-sparing diuretics reduced the risk of Alzheimer's disease (AD) by >70% in patients aged >64 years while other antihypertensive (AH) medications, including all diuretics, beta blockers, and dihydropyridine calcium channel blockers, were linked with somewhat smaller decreases in Alzheimer's risk.

Ambrisentan, a propanoic acid type-A selective endothelin receptor antagonist, improved exercise capacity and delayed clinical worsening in patients with pulmonary arterial hypertension (PAH) in phase 3 clinical trial results presented at the annual international conference of the American Thoracic Society in San Diego, Calif.

The anticonvulsant lacosamide is effective in relieving diabetic neuropathy and produces increased pain reduction with continued treatment for 22 months, according to phase 3 study results presented during the 25th Annual Scientific Meeting of APS in San Antonio, Texas. "This is a promising treatment that maintains a long-term effect," said Tibor Hidvegi, MD, Medical Department, Petz Hospital, Gyor, Hungary.

Morphine extended-release once daily significantly reduced pain among patients with chronic, moderate-to-severe low back pain compared with oxycodone controlled-release twice daily, according to results of a study presented at the 25th Annual Scientific Meeting of the American Pain Society (APS) in San Antonio, Texas. The once-daily opioid also demonstrated significant improvement in sleep scores, said Richard L. Rauck, MD, Carolinas Pain Institute, Winston-Salem, NC.

Valsartan is associated with a reduction in the levels of high-sensitivity C-reactive protein (hs-CRP), the inflammatory marker that is highly predictive of adverse cardiovascular outcomes, independent of its blood pressure-lowering effect, said Paul M. Ridker, MD, MPH, lead investigator of a trial presented at the 21st annual meeting of ASH.

In 2001, off-label drug prescriptions accounted for 150 million (21%) of the estimated 725 million prescriptions written in the United States, according to the 2001 IMS Health National Disease and Therapeutic Index (NDTI). However, according to a study published in the Archives of Internal Medicine, 73% of the off-label medication prescriptions the authors researched (95% CI, 61%–84%) had little or no scientific backing.